Prior Authorization Conditions for Approval of Hepatitis C Agents

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1 Prior Authorization Conditions for Approval of Hepatitis C Agents All requests for Hepatitis C Agents require a prior authorization and will be screened for medical necessity and appropriateness using the criteria listed below. Coverage is provided for members with chronic Hepatitis C Virus (HCV) Genotypes 1 6 in the following situations: The member is at least 18 years of age The treatment regimen is being prescribed by a qualified specialist (infectious disease, gastroenterology, hepatology, transplant) The member has a documented diagnosis of chronic HCV and completed genotyping and meets the criteria for coverage based on HCV genotype as outlined below The member has not previously had an incomplete course or treatment failure with the drug or any component of the regimen requested. If the member has a history of failure with previous Hepatitis C treatment, documentation is provided that indicates the reason for failure, which may include (but is not limited to) non compliance, safety, tolerability, or efficacy. In addition, documentation must be provided indicating that the reasons for the previous treatment failure have been addressed (e.g. re education and review of the collaborative treatment agreement) The member has documented liver biopsy or liver fibrosis panel results with a fibrosis score corresponding to Metavir F3 or greater and/ or one of the following: HIV or Hepatitis B (HBV) coinfection, history of liver transplant, severe extrahepatic manifestations of Hepatitis C (i.e. type 2 or 3 essential mixed cryoglobulinemia with end organ manifestations such as vasculitis; nephrotic syndrome, or membranoproliferative glomerulonephritis) otherwise demonstrating advanced liver fibrosis deeming treatment medically necessary per the terms below. Notwithstanding fibrosis score, treatment shall be covered upon a showing of medical necessity, which may include documentation of: o Extrahepatic symptoms that affect ADLs including but not limited to: fatigue, nausea, mental changes, joint pain, depression, sore muscles, arthritis, nerve damage and jaundice OR o Diagnosis of at least one (1) of the following co morbidities: o HIV+ o Hepatitis B infection o Lymphoma o Awaiting or post solid organ transplant (e.g. heart, kidney, liver) o Documentation of labs or biopsy showing fast progressing fibrosis that would require treatment earlier than the approved fibrosis stage OR o Other showing of medical necessity supported with appropriate physician documentation. If the member is actively abusing alcohol or IV drugs, or has a history of abuse, there is documentation of prescriber counseling regarding the risks of alcohol or IV drug abuse and an offer of referral for substance abuse disorder treatment and case management. For regimens containing sofosbuvir, the member does not have renal impairment or end stage renal disease (GFR <30 ml/min/1.73m 2 ) The member has committed in writing to the treatment agreement, acknowledging and agreeing to the planned treatment course, adherence to the planned medication regimen, on time refills, and anticipated blood tests and office visits, both during and after treatment The member s HCV RNA levels prior to treatment (within the past 3 months), their treatment status (naïve or experienced)), the planned treatment regimen,the planned start date and documentation of a viral load two weeks after treatment is initiated to demonstrated drug utilization will be documented The member will be obtaining the medication from a qualified specialty pharmacy. Clients with co morbid HIV must have undetectable HIV viral load or a CD4 count of at least 350 cells/µl. Coverage will be provided as long as the member satisfies the criteria for HCV mono infected patients (based on genotype). In all situations where coverage is approved, authorizations will be provided in four week intervals. A re authorization will be required every four weeks, demonstrating that the member is adherent to the medication regimen and has not discontinued treatment. Page 1 of 5

2 Approval of a non preferred agent requires A documented failure or contraindication to an alternative preferred regimen. o If the client has failed prior therapy, then documentation of the reason for failure is required. Simple noncompliance with previous therapy may be considered a contraindication to retreatment. o If a preferred regimen is contraindicated due to a comorbid condition, then documentation of the other condition is required. Documentation of an imminent need to initiate therapy such as cirrhosis or a pending liver transplant. o Cirrhosis can be documented based on a liver biopsy, or by other objective laboratory test demonstrating liver fibrosis corresponding to Metavir score of 4. o Alternatively, cirrhosis can be documented by a combination of an ultrasound or CT scan along with extrahepatic manifestations or clinical findings such as the presence of ascites. For the treatment of HCV Genotype 1a or Genotype 1 with an indeterminate subtype, coverage is provided in the following situations: o If the member is HCV treatment naïve and non cirrhotic, o Zepatier is being prescribed for 12 weeks. If the member is treatment naïve with cirrhosis, Zepatier is being prescribed for 12 weeks, o If the member is HCV treatment experienced) and is non cirrhotic or has cirrhosis, Zepatier is being prescribed for 12 weeks o Daily fixed dose combination of elbasvir/grazoprevir with weight based ribavirin for 16 weeks will be approved for members with HCV genotype 1a infection regardless of cirrhosis status, in whom prior PEG IFN/RBV treatment has failed and who have baseline NS5A RAVS for elbasvir. For the treatment of HCV Genotype 1b, coverage is provided in the following situations: o If the member is treatment naïve or treatment experienced and is either non cirrhotic or has cirrhosis, Zepatier is being prescribed for 12 weeks For the treatment of HCV Genotype 2, coverage is provided in the following situations: o If the member is treatment naïve or treatment experienced and non cirrhotic, Sovaldi (sofosbuvir) is being prescribed in combination with weight based ribavirin for a duration of 12 weeks o If the member is treatment naïve or treatment experienced and has cirrhosis, Sovaldi (sofosbuvir) is being prescribed in combination with weight based ribavirin for a duration of 16 to 24 weeks. For the treatment of HCV Genotype 3, coverage is provided in the following situations: o If the member is treatment naïve or treatment experienced and is non cirrhotic, Daklinza (daclatasvir) is being prescribed in combination with Sovaldi (sofosbuvir) for 12 weeks o If the member is treatment naïve or treatment experienced and has cirrhosis, Daklinza (daclatasvir) is being prescribed in combination with Sovaldi (sofosbuvir) for a duration of 24 weeks with or without weight based ribavirin. For the treatment of HCV Genotype 4, coverage is provided in the following situations: o If the member is treatment naïve or treatment experienced and is either non cirrhotic or has cirrhosis, Zepatier is being prescribed for 12 weeks For the treatment of HCV Genotype 5 or 6, coverage is provided in the following situations: o If the member is treatment naïve or treatment experienced and is non cirrhotic or has cirrhosis, Harvoni (ledipasvir/sofosbuvir) is being prescribed for a duration of 12 weeks Page 2 of 5

3 For the treatment of HCV in members with hepatocellular carcinoma awaiting liver transplantation, coverage is provided in the following situations: o If the member fulfills MILAN criteria for liver transplantation AND Harvoni is prescribed in combination with low initial dose of ribavirin for 12 weeks.. Requests for medication regimens not outlined in this policy or when criteria are not met, the request will be forwarded to a Medical Director for review. The physician reviewer must override criteria when, in their professional judgment, the requested medication is medically necessary. Page 3 of 5

4 Hepatitis C Agents INITIAL AUTHORIZATION ONLY PRIOR AUTHORIZATION FORM Please complete and fax all requested information below including any progress notes, laboratory test results, or chart documentation as applicable to Health Options Pharmacy Services. FAX: If needed, you may call to speak to a Pharmacy Services Representative. PHONE: Monday through Friday 8:30am to 5:00pm Requesting Physician: Physician Specialty: Office Address: Patient Name: Health Options ID: PROVIDER INFORMATION NPI: Office Contact: Office Phone: Office Fax: MEMBER INFORMATION DOB: REQUESTED DRUG INFORMATION Strength: Duration: Medication: Frequency: Planned HCV Treatment Regimen: MEDICAL HISTORY Has the patient previously failed treatment with Sovaldi or another HCV treament regimen? Yes No Diagnosis: Hepatitis C Virus Other: HCV Genotype: Hepatitis C Viral Load: Has the patient had a liver biopsy or liver fibrosis panel? Yes No If Yes, please list METAVIR Score Does the patient have hepatocellular carcinoma and awaiting liver transplant? Yes No What is the patient s HCV treatment status? Treatment Naïve Treatment experienced Is the patient co infected with HIV? Yes No If yes, please list CD4 Cell Count If the patient is treatment experienced, please list the previous treatment regimens used and the reasons for failure: Does the patient have a known substance or alcohol abuse diagnosis or is actively abusing alcohol or IV drugs? No If YES, has the patient been counseled by the prescriber regarding the risks of alcohol or IV drug abuse and been offered a referral for substance use disorder treatment? Yes No Yes Will the patient obtain the medication from a specialty pharmacy?? Yes No Were all pertinent lab work, fibrosis testing, viral load, treatment agreement and any other medical necessity paperwork submitted as attachements? Yes No What is the start date of the patient s HCV Treatment Regimen? SUPPORTING INFORMATION or CLINICAL RATIONALE Prescribing Physician Signature Date Page 4 of 5

5 Hepatitis C Agents REAUTHORIZATION ONLY PRIOR AUTHORIZATION FORM Please complete and fax all requested information below including any progress notes, laboratory test results, or chart documentation as applicable to Health Options Pharmacy Services. FAX: If needed, you may call to speak to a Pharmacy Services Representative. PHONE: Monday through Friday 8:30am to 4:30pm Requesting Physician: Physician Specialty: Office Address: Patient Name: Health Options ID: Medication: Frequency: PROVIDER INFORMATION NPI: Office Contact: Office Phone: Office Fax: MEMBER INFORMATION DOB: DRUG INFORMATION Strength: Duration: MEDICAL HISTORY What treatment regimen is the patient taking? Harvoni x 12 weeks Daklinza/Sovaldi x 12 weeks Harvoni/Ribavirin x 12 weeks Daklinza/Sovaldi/Ribavirin x 122 weeks Viekira Pak/Ribavirin x 12 weeks Sovaldi/Ribavirin x 12 weeks Viekira Pak/Ribavirin x 24 weeks Technivie/Ribavirin x 12 weeks Hepatocellular carcinoma awaiting liver transplant Sovaldi/Ribavirin up to 48 weeks What date did the patient begin treatment with the indicated regimen? 48 Week Regimens 24 Week Regimens 12 Week Regimens Re Authorization Date of Last Office Visit or Patient Contact Has the patient been adherent to the prescribed treatment regimen? (Please provide supporting information) Re Authorization #1 (Weeks 5 8) Yes No Re Authorization #2 (Weeks 9 12) Yes No Re Authorization #3 (Weeks 13 16) Yes No Re Authorization #4 (Weeks 17 20) Yes No Re Authorization #5 (Weeks 21 24) Yes No Re Authorization #6 (Weeks 25 28) Yes No Re Authorization #7 (Weeks 29 32) Yes No Re Authorization #8 (Weeks 33 36) Yes No Re Authorization #9 (Weeks 37 40) Yes No Re Authorization #10 (Weeks 41 44) Yes No Re Authorization #11 (Weeks 45 48) Yes No SUPPORTING INFORMATION or CLINICAL RATIONALE Prescribing Physician Signature Date Page 5 of 5

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